Principal Clinical Scientist, Rare Autoimmune / Nephrology

Company Description

Biogen's West Coast hub is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

Job Description

Biogen is seeking a Principal Clinical Scientist to support clinical research activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. This position provides leadership in program development, execution, innovation, and optimization of clinical trials by including the latest insights on disease mechanisms, diagnostic approaches, and alternative therapies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations and gaining comprehensive knowledge of the literature related to the product(s) in development.  Furthermore, responsibilities may include collaborating with Regulatory on document preparation and submission, as well as collaboration with Discovery, Development, and Commercial functions as needed and appropriate. The responsibilities of this role may vary depending on the specific indication and program requirements.

The Principal Clinical Scientist collaborates closely with Study Physicians/Scientists as a key member of the development and study teams. The role actively contributes scientific expertise to cross-functional clinical teams involved in the development of novel therapies. As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings. Our ideal candidate will have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams.

What You Will Do

• Support the preparation of clinical development plans, trial protocols, case report forms, and study operational plans that are scientifically rigorous, clinically relevant, operationally feasible, while adhering to GCP and regulatory requirements
• Establish and maintain credible relationships with clinical investigators and medical/scientific experts
• Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
• Assist Data Management with the review of clinical data and resolution of queries
• Perform medical monitoring activities and reporting in partnership with Study Responsible Physicians/Scientists, including evaluating clinical trial adverse events and reviewing clinical laboratory results
• Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials
• Draft and coordinate completion of clinical study reports
• Prepare responses to questions from Ethics Committees and Health Authorities
• Support integrated document development for marketing authorization filing
• Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
• Support preparation for FDA Advisory Committee and EU Oral Explanation
• Present relevant clinical data to internal and external stakeholders
• Review medical literature and related new technologies relevant to the assigned projects.
• Other responsibilities may include utilizing nonclinical PK and PK/PD data (including use of modeling and simulation techniques) to project optimal clinical dosing regimens, doses based on pharmacological/clinical targets, human starting doses, and biomarker exploratory data (including biochemical and molecular data from quantification of mRNA, multi-panel flow cytometry, and protein expression)

This position is Hybrid based and travel to our South San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires.

Who You Are

You are experienced with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications.  You excel in a fast paced environment and enjoy collaborating cross functionally with discovery, development, and commercial colleagues.

Qualifications

Required Experience

• MD/PhD/PharmD with 5+ years of industry clinical research experience, preferably in nephrology, immunology or a related therapeutic area.